• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards | Inspections
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name port & catheter, implanted, subcutaneous, intravascular
510(k) Number K120281
Device Name DIGNITY POWER INJECTABLE TITANIUM PORT
Original Applicant
MEDICAL COMPONENTS INC
1499 delp drive
harleysville,  PA  19438
Original Contact rosanna severini
Regulation Number880.5965
Classification Product Code
LJT  
Date Received02/13/2012
Decision Date 09/17/2012
Decision substantially equivalent (SE)
Classification Advisory Committee General Hospital
Review Advisory Committee General Hospital
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
-
-